NCT06189963 · NKGen Biotech, Inc.
Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease
What this study is about
The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are: 1. Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an given through a vein (IV) infusion 2.
View original scientific description
The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are: 1. Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion 2.
Interventions
BIOLOGICAL
SNK01
SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug
OTHER
Placebo
Sodium Lactate Hartmann's Solution
Primary outcome measures
Number of participants with dose-limiting toxicity
Time frame: 3 weeks
DLTs will be assessed by the review of labs, PE and AEs
Maximum tolerated dose determination
Time frame: 3 weeks
Determine the maximum tolerated dose based on the evaluation of the number of participants who experience a DLT which will then determine the RP2D.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 1 Year
Evaluate the safety and tolerability of SNK01 assessed by labs, PE and AEs
Preliminary efficacy in cognitive assessment scores of CDR-SB
Time frame: 1 Year
Measure changes in cognitive assessment of CDR-SB from baseline
Preliminary efficacy in cognitive assessment scores of MMSE
Time frame: 1 Year
Measure changes in cognitive assessment of MMSE from baseline
Preliminary efficacy in cognitive assessment scores of NPI
Time frame: 1 Year
Measure changes in cognitive assessment of NPI from baseline
Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe
Time frame: 1 Year
Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline
Preliminary efficacy in cognitive assessment scores of ADAS-Cog
Time frame: 1 Year
Measure changes in cognitive assessment of ADAS-Cog from baseline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The participant or their legally authorized representative must be willing and able to give their informed consent in writing and comply with the requirements of this study protocol. Informed consent for participants or their legally authorized representative and caregivers will be obtained before any trial-related activity. (Trial-related activities are any procedure that would not be performed during normal treatment of the participant). 2. Participants must have a reliable study partner/caregiver (per investigator judgement for instance a family member, partner etc., guardian (must be always the same person)) who is in close contact with the patient, available on call and who is able to contribute to the assessment of the ratings of the functional endpoints at specific study visits. This person will be able to communicate in the language in which the participant is being assessed and should also serve as a backup contact for the study site. The study partner/
Where
- Glendale, California
- Santa Ana, California
- Tarzana, California
- Maitland, Florida
- Orlando, Florida
- Newark, New Jersey
- Albany, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations